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Vitamin A Absorption From Cassava in Women (FL-80)

Primary Purpose

Vitamin A Deficiency

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Beta-Carotene bio-fortified cassava porridge without oil
Beta-Carotene bio-fortified cassava porridge with oil
White cassava porridge with retinyl palmitate reference dose
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin A Deficiency focused on measuring Vitamin A

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • non-smoking
  • BMI between 18-30
  • total cholesterol concentrations between 90 and 225 mg/dL
  • blood pressure under 140/90 mm Hg
  • hemoglobin above 11.5 g/dL
  • blood chemistries within the normal range

Exclusion Criteria:

  • must not be pregnant or trying to get pregnant
  • must not be taking fat, triacylglycerol, or cholesterol lowering medications) such as orlistat, gemfibrozil, niacin, lovastatin, simvastatin, colestipol, and ezetimibe)
  • must not taking medicines containing high doses of retinoids such as Accutane or high vitamin A or carotenoid supplements
  • must not have blood chemistry or health history results consistent with acute cancer or heart disease
  • no obvious psychological or sociological problems such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an informed consent agreement or to participate in study duties and activities
  • must not be allergic to cassava, peanuts, or peanut oil

Sites / Locations

  • Western Human Nutrition Center, University of California Davis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Cassava Treatment 1

Cassava Treatment 2

Cassava Treatment 3

Arm Description

Single meal containing bio-fortified, high carotenoid cassava without oil.

Single meal containing bio-fortified, high carotenoid cassava with oil.

Single meal containing low carotenoid cassava with oil and retinyl palmitate.

Outcomes

Primary Outcome Measures

Vitamin A equivalency from varieties of cassava with and without oil
Vitamin A and other carotenoids will be measured in triacylglycerol rich lipoprotein fractions at 0, 60, 150, 240, 330, 420, 510, 600, and 1440 minutes after consumption of cassava containing meal.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2011
Last Updated
December 8, 2011
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
HarvestPlus
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1. Study Identification

Unique Protocol Identification Number
NCT01381276
Brief Title
Vitamin A Absorption From Cassava in Women
Acronym
FL-80
Official Title
Vitamin A Equivalence of Carotenoids From Cassava in Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
HarvestPlus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava.
Detailed Description
We plan to conduct a single site intervention phase II intervention study in healthy adult women. Women will serve as their own controls, and will be fed three treatments in random order: a single meal of low-carotenoid cassava porridge with fat, a similar meal of bio-fortified cassava (that is high in vitamin A-forming carotenoids) with fat, and a similar meal of bio-fortified cassava without fat. Carotenoids and vitamin A will be measured in the triacylglycerol-rich lipoprotein (TRL) fraction of plasma by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection. We plan to collect sufficient data to identify the times of the first appearance and peak concentrations in retinol, retinyl esters, alpha-carotene (AC), beta-carotene (BC), beta-carotene isomers (BCI), and cryptoxanthin (CX) in TRL: when a single meal containing moderately high amounts of carotenoids from bio-fortified cassava is fed to healthy adult women. We will use this data to determine the vitamin A equivalency of bio-fortified cassava in adult women, and the effect of fat on vitamin A equivalency of bio-fortified cassava.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
Keywords
Vitamin A

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cassava Treatment 1
Arm Type
Experimental
Arm Description
Single meal containing bio-fortified, high carotenoid cassava without oil.
Arm Title
Cassava Treatment 2
Arm Type
Experimental
Arm Description
Single meal containing bio-fortified, high carotenoid cassava with oil.
Arm Title
Cassava Treatment 3
Arm Type
Active Comparator
Arm Description
Single meal containing low carotenoid cassava with oil and retinyl palmitate.
Intervention Type
Other
Intervention Name(s)
Beta-Carotene bio-fortified cassava porridge without oil
Intervention Description
300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene.
Intervention Type
Other
Intervention Name(s)
Beta-Carotene bio-fortified cassava porridge with oil
Intervention Description
300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene.
Intervention Type
Other
Intervention Name(s)
White cassava porridge with retinyl palmitate reference dose
Intervention Description
300 g porridge containing 15 mL peanut oil, 100 g drained mashed cassava, and a tracer of approximately .3 mg pure food-grade retinyl palmitate.
Primary Outcome Measure Information:
Title
Vitamin A equivalency from varieties of cassava with and without oil
Description
Vitamin A and other carotenoids will be measured in triacylglycerol rich lipoprotein fractions at 0, 60, 150, 240, 330, 420, 510, 600, and 1440 minutes after consumption of cassava containing meal.
Time Frame
0, 60, 150, 240, 330, 420, 510, 600, 1440 min

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non-smoking BMI between 18-30 total cholesterol concentrations between 90 and 225 mg/dL blood pressure under 140/90 mm Hg hemoglobin above 11.5 g/dL blood chemistries within the normal range Exclusion Criteria: must not be pregnant or trying to get pregnant must not be taking fat, triacylglycerol, or cholesterol lowering medications) such as orlistat, gemfibrozil, niacin, lovastatin, simvastatin, colestipol, and ezetimibe) must not taking medicines containing high doses of retinoids such as Accutane or high vitamin A or carotenoid supplements must not have blood chemistry or health history results consistent with acute cancer or heart disease no obvious psychological or sociological problems such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an informed consent agreement or to participate in study duties and activities must not be allergic to cassava, peanuts, or peanut oil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty J Burri, PhD
Organizational Affiliation
WHNRC, ARS, University of California Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Human Nutrition Center, University of California Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

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Vitamin A Absorption From Cassava in Women

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